On 12 August, 2022, Law No. 118 of Aug. 5, 2022, (“Competition Law 2021”), containing provisions aimed at protecting competition and the overall consumers, was published in the Official Gazette. The law came into effect on August 27, except for Article 31, which will be effective as from January 1, 2023.
Provisions affecting the Life Sciences sector are contained in Chapter V of the Law. Among others:
- Article 16, which amends Article 105, co.1(b), Legislative Decree 219/2006 (the so-called “Drug Code”), which requires the wholesaler to keep a minimum 90% stock of medicines authorized to the marketing. The current version removes this threshold by establishing the wholesaler is required to hold at least “a stock (….), including authorized homeopathic medicines […] and generic medicines, which is such as to meet the needs of the geographically determined territory to which the wholesale distribution authorization refers to, as assessed by the competent authority on the basis of binding guidelines provided by AIFA”. This obligation “does not apply to medicines not eligible for reimbursement by the NHS, without prejudice to the possibility of the retailer to obtain supplies from another wholesaler.”
- Article 17 repeals para. 1-bis of Legislative Decree 158/2012 (the so-called the “Balduzzi Decree”) and stipulates that manufacturers of generic drugs may submit an application to AIFA for the issuance of a marketing authorization and for the pricing and reimbursement, before the patent or supplementary protection certificate expires. The rules on patent linkage, however, remain unchanged, whereby the reimbursement of such drugs by the NHS can only take place “from the date of expiration of the patent or certificate” or originator supplementary protection certificate (SPC).
- Art. 18 amends para. 5b of Art. 12, Decree Law 158/2012, providing that for drugs awaiting price definition, “in the event of failure to submit within thirty days of the issuance of the marketing authorization of a drug referred to in paragraph 3, AIFA shall urge the company holding the relevant marketing authorization to submit the application for classification referred to in paragraph 1 within the next thirty days. If this deadline expires unsuccessfully, notice shall be given on AIFA’s institutional website and alignment to the lowest price within the fourth level of the anatomical therapeutic chemical (ATC) classification system shall be applied.”
- Finally, it is worth noting Art. 15 on rules on “Review and transparency of accreditation and contracting of private facilities as well as monitoring and evaluation of private contracted providers”; Art. 19 on “review of the system of production of blood-derived medicinal products from Italian plasma”; Art. 20, which defines procedures for the appointment of healthcare management; as well as Art. 21 on “procedures related to managerial training in public health.”
30 August, 2022
The above note is for information only and may not be intended as a substitute for a considered and specific legal opinion.